phoenix atherectomy system
Volcano Atheromed
FDA Clearance Information
The Phoenix Atherectomy System was cleared by the FDA via the 510(k) pathway on December 20, 2018. It is manufactured by Volcano Atheromed and classified as a Class 2 device.
What It Is
Clinical Applications
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Linked Studies (8)
Multicenter comparison of Etest, Vitek2 and BD Phoenix to broth microdilution for beta-lactam susceptibility testing of Streptococcus pneumonia.
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
RCT|prospective|retrospective|case Series|other View Source →Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.
Vascular medicine (London, England)
View Source →Crossing complex infrapopliteal lesions utilizing a front-end cutting technique: A report of two cases with a novel rotational atherectomy device.
SAGE open medical case reports
View Source →Acute Real-World Outcomes From the Phoenix Post-Approval Registry.
The Journal of invasive cardiology
Other View Source →Phoenix atherectomy for patients with peripheral artery disease.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
RCT|prospective|retrospective|case Series|other View Source →A Single-Center Experience With Phoenix Atherectomy System in Patients With Moderate to Heavily Calcified Femoropopliteal Lesions.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →Hybrid atherectomy for lower extremity peripheral arterial disease.
Vascular
RCT|prospective|retrospective|case Series|other View Source →Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.
Vascular
View Source →Frequently Asked Questions
What are the clinical indications for Phoenix Atherectomy System?
The Phoenix Atherectomy System is indicated for the treatment of peripheral artery disease, particularly in patients with complex, calcified lesions in the femoropopliteal and infrapopliteal arteries.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the Phoenix Atherectomy System effectively debulks complex lesions, improves blood flow, and reduces stenosis in treated vessels.
What complications have been reported?
Reported complications include procedural risks such as vessel perforation and embolization, although the device generally has a favorable safety profile.